March 23, 2023

Last year, the FDA made the companies’ plans possible when the agency allowed doctors to prescribe and mail mifepristone — the first of two pills patients take with the abortion drug — via telemedicine and mail. But the FDA could change course if an anti-abortion president wins the election.

“Post-Roe America demands that we rethink where and how abortion care is delivered,” said Carolyn Witte, the co-founder and CEO of Tia, which offers telehealth appointments and abortion pills in California and New York. “We need to move from a silo approach that treats abortion as a separate issue to a full-featured female health care model.”

While primary care physicians could provide drug abortion, many are reluctant to do so. That’s because of FDA certification rules for mifepristone distributors, the need to store the pills, the controversy surrounding abortion, and the potential for being targeted by anti-abortion activists.

Most abortions in the US are drug-induced, and the online firms offer benefits to patients and doctors alike: There’s no location to pick and companies can obscure which doctors prescribe them to protect them from anti-abortion activists.

Several online abortion clinics — including Choix, Hey Jane, and Aid Access — already employ doctors certified to prescribe mifepristone. They rely on mail order pharmacies like Honeybee Health to ship the pills.

The FDA said last year it would use its enforcement freedom to allow online pharmacies to ship mifepristone by mail, as long as they worked with doctors certified to dispense the drug.

Now primary care organizations and maternity care companies such as Millie Clinic in California and Viva Eve in New York, both of which offer face-to-face and virtual appointments, offer drug abortion to patients.

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Telehealth company Wisp provides drug abortion to patients in California, New York, Illinois, Colorado, Maryland, Maine and Washington. Carbon Health, which provides personal primary care in 17 states and telehealth in 23 states, now offers drug abortion throughout California and plans to expand to every state where abortion is legal.

Roadblocks for doctors

Three percent of newly graduated general practitioners provide some form of abortion care, according to a 2018 study. And the vast majority of midwiveswho specialize in reproductive health care do not perform abortions.

FDA restrictions on the distribution of mifepristone, which are designed to mitigate safety concerns, are a barrier, doctors say. Distributors must be certified by the drug’s manufacturers, a process overseen by the FDA.

Doctors willing to hand out the pills must demonstrate that they understand that mifepristone is used to induce abortions, that it does so by blocking hormones needed to keep a fetus in the womb, and that they understand how to treat patients should advise on its use. They must also have patients sign a disclosure form acknowledging that they know they are taking mifepristone to terminate a pregnancy.

In addition to FDA regulations, some states require abortion patients to have ultrasounds, make multiple trips to a clinic before undergoing the procedure, or ban telemedicine abortion altogether.

Hyde Amendment Prevents “Federally Qualified Health Centers” – Community Clinics That Receive and Serve Federal Funding 30 million Americans – of using federal dollars for abortion. Doctors who want to give drug abortions endanger themselves and their clinics with intimidation and more expensive liability insurance. (New York State has recently passed a law to prevent malpractice insurers from charging higher rates to abortion providers.)

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In a small survey of 48 physicians about barriers to prescribing medication abortion, published this year by the Journal of the American Board of Family Medicine, one doctor said, “I’d do it in a heartbeat if I could prescribe mifepristone, and my patient could pick it up from a commercial pharmacy, but she can’t because of the way it is regulated by the FDA.”

Pills by mail

For years, certified physicians could only administer mifepristone to patients personally. That changed during the pandemic when a Maryland federal court judge, Theodore Chuang, approved an order sought by physician groups allowing for abortion medications to be prescribed via telehealth and mailed for the duration of the federal public health emergency.

The Supreme Court the personal prescribing requirement restored in January 2021 at the request of the FDA while Donald Trump was still president. However, after Joe Biden was elected, the agency changed course and allowed prescriptions by telemedicine, allowing the pills to be sent by mail or dispensed by local pharmacies. A new president could reverse that.

And the FDA is reviewing applications from the manufacturers of mifepristone to determine how nearby pharmacists can safely dispense it in their brick-and-mortar stores. GenBioPro and Danco Laboratories submitted proposals in June. The FDA has six months to take action on the filing.

For abortion rights advocates, the new interest of primary care organizations in prescribing drug abortion is a bright spot emerging after the Supreme Court decision.

“The more we can normalize and spread abortion care across more providers, the more we spread the risk and normalize this health care,” Upadhyay says.

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Online access to pills is not a panacea for abortion patients in states where the procedure is banned. They must travel to states where it is legal to meet with a doctor, both in person and online. And maybe they can’t get pills to their home address.

Upadhyay said she would like the FDA to update its certification rules so that pharmacies can apply to distribute mifepristone. The University of California has expressed interest in providing medication abortion at the campus pharmacies.

Of course, health care providers who prescribe drug abortion – online or offline – are still at risk. Alpha Medical, an online primary care provider, plans to implement drug abortion later this year, but is still working on the law. Mary Jacobson, Alpha Medical’s chief medical officer, said she is concerned that if she prescribes drug abortion in states where it is legal, her medical license could be revoked in states where it is prohibited.

She said Alpha Medical faces similar legal risks when it connects patients to abortion tools: “If someone from Texas contacts us for navigation, are we considered an accomplice if we give advice?”